Amylyx’s Relyvrio (sodium phenylbutyrate and taurursodiol) Receives the US FDA’s Approval for the Treatment of ALS
Shots:
- The US FDA has approved Relyvrio (sodium phenylbutyrate and taurursodiol) for the treatment of adults with ALS
- The approval was based on the P-II (CENTAUR) OLE long-term follow-up phase trial to evaluate Relyvrio in 137 patients with ALS. The results showed a slowed loss of physical function & were published in the NEJM, Muscle & Nerve, and the Journal of Neurology, Neurosurgery & Psychiatry
- Relyvrio is an oral, fixed-dose combination therapy approved to treat adult patients with ALS in the US & approved as Albrioza for ALS in Canada. The MAA of AMX0035 is currently under the EMA’s review for ALS in the EU while the company also advanced the therapy for other neurodegenerative diseases
Ref: Amylyx | Image: Amylyx
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